ANSPACH OPERATING TABLE SUPPORT/SPINAL
FDA 510(k) clearance K801326 · decided 1980-06-26
Clearance details
- K-number
- K801326
- Device name
- ANSPACH OPERATING TABLE SUPPORT/SPINAL
- Applicant
- The Anspach Effort, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1980-06-03
- Decision date
- 1980-06-26
- Days to decision
- 23 days
- Clearance type
- Traditional
- Product code
- EPW
- Device class
- 1
- Regulation number
- 878.4950
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| HEAD-UP SUPINE SAFETY SUPPORT CUSHION (K821306) | Med-Life, Inc. | 1982-06-07 |
Recalls involving this device
No recalls on record reference this clearance.